Clinical Trials Register

Summary
EudraCT Number:	2011-004433-14
Sponsor's Protocol Code Number:	A3L15
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2012-04-10
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2011-004433-14

A.3

Full title of the trial

Randomized, open, controlled, multicenter, Phase III trial in infants who will receive DTaP-IPV-Hep B-PRP-T (Group 1, N=286), CombAct-Hib™ and Engerix B™ Pediatric with OPV (Group 2, N=286), or DTaP-IPV-Hep B-PRP-T with Engerix B™ Pediatric at birth (Group 3, N=143). A booster dose of DTaP-IPV-Hep B-PRP-T (Groups 1 and 3) or CombAct-Hib™ and OPV (Group 2), with Trimovax™ and Varilrix™, will be administered at 15 to 18 months of age.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Immunogenicity Study of a DTaP-IPV-Hep B-PRP-T Combined Vaccine in Comparison to CombAct-Hib™ Concomitantly Administered with Engerix B™ Paediatric and OPV at 6, 10, and 14 weeks of Age in South African Infants

A.4.1

Sponsor's protocol code number

A3L15

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00362336

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/015/2012

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sanofi Pasteur SA
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sanofi Pasteur SA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sanofi Pasteur SA
B.5.2	Functional name of contact point	Director, Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	1541, Avenue Marcel Mérieux
B.5.3.2	Town/ city	Marcy l'étoile
B.5.3.3	Post code	69280
B.5.3.4	Country	France
B.5.4	Telephone number	33(0)4 37 37 58 53
B.5.5	Fax number	33(0)4 37 37 74 38
B.5.6	E-mail	eduardo.santos-lima@sanofipasteur.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Hexaxim
D.3.2	Product code	DTaP-IPV-HepB-PRP-T vaccine
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	D
D.3.9.3	Other descriptive name	DIPHTHERIA TOXOID
D.3.9.4	EV Substance Code	SUB12489MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	T
D.3.9.3	Other descriptive name	TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB12608MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	PT
D.3.9.3	Other descriptive name	PERTUSSIS TOXOID
D.3.9.4	EV Substance Code	SUB14817MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	FHA
D.3.9.3	Other descriptive name	PERTUSSIS FILAMENTOUS HAEMAGGLUTININ
D.3.9.4	EV Substance Code	SUB20298
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25669
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25670
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25671
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	32
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Hep B
D.3.9.3	Other descriptive name	HEPATITIS B SURFACE ANTIGEN
D.3.9.4	EV Substance Code	SUB14083MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	HAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB25275
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CombAct-Hib™
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur SA
D.2.1.2	Country which granted the Marketing Authorisation	South Africa
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tetract-Hib
D.3.4	Pharmaceutical form	Powder and suspension for suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	D
D.3.9.3	Other descriptive name	DIPHTHERIA TOXOID
D.3.9.4	EV Substance Code	SUB12489MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	T
D.3.9.3	Other descriptive name	TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB12608MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	60
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	BORDETELLA PERTUSSIS (INACTIVATED)
D.3.9.4	EV Substance Code	SUB20503
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Hep B
D.3.9.3	Other descriptive name	HEPATITIS B SURFACE ANTIGEN
D.3.9.4	EV Substance Code	SUB14083MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	HAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB25275
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OPVERO (Oral Poliomyelitis Vaccine)
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur SA
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	OPVERO (Oral Poliomyelitis Vaccine)
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 1
D.3.9.4	EV Substance Code	SUB25623
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50 cell culture infective dose 50
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1000000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 2
D.3.9.4	EV Substance Code	SUB25624
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50 cell culture infective dose 50
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	100000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 3
D.3.9.4	EV Substance Code	SUB25625
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50 cell culture infective dose 50
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	630958
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Engerix B™
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Engerix B
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	HEPATITIS B SURFACE ANTIGEN
D.3.9.4	EV Substance Code	SUB14083MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus

E.1.1.1

Medical condition in easily understood language

Active immunisation against diphtheria,tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10021430
E.1.2	Term	Immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10036897
E.1.2	Term	Prophylactic vaccination
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	HLT
E.1.2	Classification code	10021431
E.1.2	Term	Immunisations
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	HLGT
E.1.2	Classification code	10043413
E.1.2	Term	Therapeutic procedures and supportive care NEC
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP-T combined vaccine does not induce a lower immune response than CombAct-Hib™ with Engerix B™ Pediatric and OPV in terms of seroprotection rates to D, T, polio, Hep B, and polyribosyl ribitol phosphate (PRP), 1 month after a three-dose primary series (at 6, 10, and 14 weeks) with no Hep B vaccination at birth.

E.2.2

Secondary objectives of the trial

Immunogenicity
To describe in each group:
• The immunogenicity parameters for each primary series vaccine component 1 month after the third dose of the primary series
• The Ab persistence for each primary series vaccine component prior to a booster vaccination at 15 to 18 months of age
• The immunogenicity parameters to each primary series vaccine component 1 month after a booster vaccination at 15 to 18 months of age
• The immunogenicity parameters to measles, mumps, and rubella (MMR) and varicella 1 month after a booster vaccination at 15 to 18 months of age

Safety

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) 0 to 3 day old infants
2) Mother sero-negative for Human Immunodeficiency Virus (HIV) after 24 weeks’ gestation
3) Born at full-term of pregnancy (≥37 weeks, assessed by a physician at the time of birth) with a birth weight ≥2.5 kg
4) Apgar score >7 at 5 or 10 minutes of life
5) Informed Consent Form (ICF) signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian was illiterate
6) Able to attend all scheduled visits and to comply with all trial procedures
7) For the booster phase only: Informed Consent Form (Addendum 1 to the ICF, see Appendix 4) signed by a parent or legal guardian, and by an independent witness if the parent / legal guardian was illiterate (collected before or at V07). This inclusion criterion had to be checked at V07 only.
8) For the booster phase only: Toddlers aged 15 to 18 months on the day of inclusion (range: 456 to 578 days of age, inclusive). This inclusion criterion had to be checked at V07.

E.4

Principal exclusion criteria

1) Current or planned participation in another clinical trial during the entire duration of the present trial
2) Suspected congenital or acquired immunodeficiency
3) Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history.
4) Chronic illness at a stage that could have interfered with trial conduct or completion.
5) Blood or blood-derived products received since birth
6) Any planned vaccination (except BCG vaccination and trial vaccinations) from birth to V05 (18 weeks of age)
7) Oral poliovirus vaccine administration at birth
8) Known maternal history of HIV, Hep B (HBsAg), or hepatitis C seropositivity
9) Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
10) History of seizures
11) Febrile (axillary temperature ≥37.4°C) or acute illness on the day of inclusion

E.5 End points

E.5.1

Primary end point(s)

The following serological endpoints were assessed 1 month after the third dose of the primary series (i.e. at V05 [18 weeks of age]) with seroprotection being defined as:
• Anti-T antibody (Ab) titers ≥0.01 International Unit (IU)/mL
• Anti-D Ab titers ≥0.01 IU/mL
• Anti-Hep Bs Ab titers ≥10 mIU/mL
• Anti-PRP Ab titers ≥0.15 μg/mL
• Anti-polio 1, 2, and 3 Ab titers ≥8 (1/dil)

E.5.1.1

Timepoint(s) of evaluation of this end point

A 3 mL blood sample (BL) was taken at 6 weeks of age (BL1-V02 [Day 42], only for PT and FHA valences), and 5 mL samples were taken at 18 weeks of age (BL2-V05 [Day 126]), at 15 to 18 months of age (BL3-V07), and at 16 to 19 months of age (BL4-V08, taken 28 to 42 days after BL3).

E.5.2

Secondary end point(s)

Immunogenicity
The following endpoints were used for the primary series:
• Anti-T and anti-D Ab titers at V05 (18 weeks of age), titers ≥0.1 IU/mL and ≥1.0 IU/mL at V05 for each group
• Anti-Hep Bs Ab titers at V05 (18 weeks of age) and titers ≥100 mIU/mL at V05 for each group
• Anti-PRP Ab titers at V05 (18 weeks of age) and titers ≥1.0 μg/mL at V05 for each group
• Anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (anti-FHA) Ab titers at V05 (18 weeks of age), titers ≥4 ELISA units (EU)/mL
• Anti-polio 1, 2, and 3 Ab titers at V05 (18 weeks of age) for each group
• Anti-T Ab titers ≥0.01 IU/mL, anti-D Ab titers ≥0.01 IU/mL, anti-Hep Bs Ab titers ≥10 mIU/mL, anti-PRP Ab titers ≥0.15 μg/mL (Group 3 only [DTaP-IPV-Hep B-PRP-T with Hep B at birth]) at V05 (18 weeks of age)
The following endpoints were used to assess the booster responses at V08:
• Ab titers for each valence
• Ab titers above a cut-off:
• Anti-T Ab titers ≥0.01 IU/mL, ≥0.1 IU/mL, and ≥1.0 IU/mL
• Anti-D Ab titers ≥0.01 IU/mL, ≥0.1 IU/mL, and ≥1.0 IU/mL
• Anti-Hep Bs Ab titers ≥10 mIU/mL and ≥100 mIU/mL
• Anti-PRP Ab titers ≥0.15 μg/mL and ≥1.0 μg/mL
• Anti-polio titers ≥8 (1/dil)
• Anti-measles (≥300 mIU/mL by enzyme-linked immunosorbent assay [ELISA])
• Anti-mumps (≥500 EU/mL by ELISA)
• Anti-rubella (≥10 IU/mL by ELISA)
• Anti-varicella (≥300 mIU/mL by ELISA)
• Seroconversion for anti-PT and anti-FHA, defined as:
• Anti-PT and anti-FHA ≥four-fold Ab titers increase from V07 to V08

Safety

E.5.2.1

Timepoint(s) of evaluation of this end point

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

South Africa

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

end of the trial = LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

715

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

715

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Vulnerable pop (enfants): ICF signed by the subject's the parent(s)/legal representative (and by an independent witness if required by
local regulations)

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

715

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not applicable

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	South Africa

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